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Recall Observatory FDA recall evidence

Device product

A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.

Z-2098-2019

June 21, 2019

Class II

Product summary

Firm
Alto Development Corp
Event
Event 83285
Status
Terminated
Classification
Class II
Quantity
351.5 Boxes
Official record key
device-enforcement:Z-2098-2019

Official wording

Reason: Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.

Code information: Lots 0715A or later

Distribution pattern: Distribution US Nationwide, Czech Republic, Italy, Israel, and UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.